Allure Labs, LLC
FDA inspection history in Hayward, California, 2011 to 2026
- 4
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2011: one warning letter; 2017: one Form 483; 2020: one Form 483; 2021: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One warning letter, at Hayward, California.
- 2017One Form 483, at Hayward, California.
- 2017The longest 483 on file: 7 observations over 11 pages at Hayward, California.
- 2020–21Two Form 483s, at Hayward, California.
- 2026One Form 483, at Hayward, California.
Cited most
Across all Allure Labs observations on file
- 21 CFR 211.165(a)Testing and release for distribution3
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.170(b)Reserve samples2
- 21 CFR 211.22(d)Responsibilities of quality control unit2
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment2
The complete Allure Labs file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Hayward, California
Four Form 483s and one warning letter · 2011 to 2026 · 21 observations
Latest: Form 483, Mar 27, 2026 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-03-27 | 483 Form 483 | Hayward, California | 3 | $99 |
| 2021-12-03 | 483 Form 483 | Hayward, California | 4 | $99 |
| 2020-11-23 | 483 Form 483 | Hayward, California | 7 | $99 |
| 2017-10-25 | 483 Form 483 | Hayward, California | 7 | $99 |
| 2011-05-24 | Warning letter Warning letter | Hayward, California | — | $99 |
Investigators on these documents
Jeffrey P. Raimondi (1)Kristin M. Abaonza (1)Nathan E. Hellman (1)Scott N. Lim (1)
FEI number 3000204079 · most recent document Mar 27, 2026
About Allure Labs, LLC
How many FDA Form 483s has Allure Labs, LLC received?
FDA Intel has 4 Form 483s on file for Allure Labs, LLC; the most recent is dated Mar 27, 2026.
When was Allure Labs, LLC last inspected by FDA?
The most recent FDA inspection document on file for Allure Labs, LLC is a Form 483 dated Mar 27, 2026, for the site in Hayward, California.
What did FDA cite at Allure Labs, LLC?
The regulations cited most in the observations on file for Allure Labs, LLC are 21 CFR 211.165(a) (Testing and release for distribution), 3 times; 21 CFR 211.100(a) (Written procedures; deviations), 2 times; 21 CFR 211.170(b) (Reserve samples), 2 times.
Has Allure Labs, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Allure Labs, LLC; the most recent is dated May 24, 2011.